Name: The Truth About COVID Vaccines and Emergency Use Authorizations
Uploaded: 2021-05-24T11:50:47.000Z
Duration: 6 min 56 s
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We've been getting lots of vaccine news for the last few weeks,

including that multiple drug developers are taking the next steps

towards rolling out vaccines to the public.

Like, on November 20th here in the US, the pharmaceutical company

Pfizer applied for an Emergency Use Authorization for

the COVID-19 vaccine developed by BioNTech.

And Moderna filed the application for theirs ten days later — on Monday.

But it also doesn't mean we have multiple vaccines about to be rolled out.

It'll likely still be months, maybe even more than a year,

before you can stroll down to your doctor's office

or local pharmacy and get one of these vaccines.

These may not even end up being the vaccines we use for this disease!

Still, there is some really awesome science to talk about here,

because these vaccines are a totally new thing!

In the last few months, you've probably heard people,

including us, talk about how vaccines take time to develop.

The design process and lab tests usually take months, sometimes even years.

But things are different during a serious emergency, like a global pandemic.

Investors inject lots of cash into drug development

to speed along the lab work and clinical trials.

Still, there's a lengthy formal approval process,

overseen here in the US by the Food and Drug Administration.

There can be a way to temporarily bypass that.

If someone above the FDA declares that there's a special kind

of medical emergency — one that goes beyond a normal “public health emergency”

— then, the FDA may consider applications for

These grant temporary, limited approval for things

Essentially, the FDA does a complex and careful risk-reward calculation.

As long as the treatment, vaccine, or test shows that it might be

effective for the declared emergency — and there are

no good alternatives — then it can be considered for an EUA.

And that's what's happened with COVID-19 and these vaccines.

To try to get an EUA, the evidence supporting these vaccines will

first be reviewed by a panel of outside scientists

and public health experts, followed by the FDA.

For the vaccine developed by BioNtech, that FDA review

That said, there's nothing that says the FDA has to grant these authorizations.

And even if they do, the companies have already made it clear

that producing enough doses to treat everyone in the US,

let alone other countries, is going to take quite a bit of time.

Any doses that become available in the next few months will likely be

first prioritized for medical personnel and other high-risk groups

That means we don't know exactly when everyone will be able to get

a vaccine, but it's not going to be soon.

Also, there's a chance that there'll be a snag along the way.

By design, EUAs last until the emergency is over,

the drug is formally approved, or new evidence emerges

that calls into question how useful the drug is.

That's what happened with the drug hydroxychloroquine:

it got an EUA for treating COVID, and then the EUA was pulled

after studies failed to find it actually helped.

And these vaccines haven't been tested in a lot of the people

we'd want to give a COVID vaccine to, like kids or people

Which is why experts are being cautious about firing

There is something kind of cool about these two vaccines

in particular, though: they're unlike any vaccines

All vaccines work by training your body to recognize

a pathogen so it can disable it and flag it for destruction.

Some vaccines do this with a dead or weakened version of the germ,

Others, like the Hep B vaccine, just contain the specific part

of the germ your immune system needs to know to take it out.

And that's kind of the path these new vaccines took — they teach your

cells to spot a part of this coronavirus called the spike protein.

But here's the big difference: they don't actually contain

that protein — they only have genetic instructions for it,

in the form of messenger RNA, or mRNA for short.

That's the same kind of molecule our cells normally use

But these ones are carefully designed and manufactured.

This manufactured mRNA gets packed into little fat-based

nanoparticles that deliver it into our cells.

Once that happens, our cells build the spike proteins

that the immune system ends up learning to spot.

So these vaccines take advantage of the fact that our cells

have all these little protein factories just waiting

for mRNA instructions to tell them what to make!

The key thing to note here is that making this kind of vaccine

doesn't require an actual sample of the live virus — just

its genome sequence, which Chinese researchers

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The Truth About COVID Vaccines and Emergency Use Authorizations

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chronic

process

immune